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Medical Daily
Medical Daily
Health
Cole Mercer

Beta Bionics Wins FDA Clearance for Mint Tubeless Insulin Patch Pump, Plans Pharmacy-Only U.S. Launch in Early 2027

People with diabetes who want to manage insulin without tubing are getting another option, though not until next year. Beta Bionics announced Monday that the Food and Drug Administration has cleared Mint, the company's first tubeless insulin patch pump, and said it expects to begin a full U.S. commercial launch in the first quarter of 2027, according to the company's clearance announcement.

The FDA made its decision Friday, according to the agency's 510(k) database entry for the Mint pump, which lists the device as the Mint ACE Pump and shows that Beta Bionics submitted it on January 2. The company plans to sell Mint only through pharmacies and expects about 40% of insured Americans to be able to buy it with their pharmacy benefit at launch, rising to at least 50% within the first year.

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